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PolyLock

FDA UDI

Class II (US FDA UDI)

by Fusion Orthopedics, Llc

Identity

Trade Name
PolyLock FDA UDI
Generic Name
General external orthopaedic fixation system implantation kit, reusable FDA UDI
Device Name
MiniLock Rotation Arm Universal FDA UDI
Model / Reference
TN-MB-7033 FDA UDI
Description
MiniLock Rotation Arm Universal FDA UDI

Identifiers

Catalog Number
TN-MB-7033 FDA UDI
Primary DI / UDI-DI
00840124511781 FDA UDI
FDA Product Code
HWC FDA UDI
GMDN Term
General external orthopaedic fixation system implantation kit, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: General external orthopaedic fixation system implantation kit, reusable

PolyLock by Fusion Orthopedics, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General external orthopaedic fixation system implantation kit, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fusion Orthopedics, Llc

Sources (1)

  • FDA UDI f3460ff7-3471-4a6d-99d9-72bb400b855f 34 fields · synced May 30, 2026